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Assistance with IND/IDE FDA ...
The IND IDE Office maintains institutional files for all FDA communication.
ClinicalTrials.gov Account Support
Request a Clinicaltrials.gov Account and Clinicaltrials.gov Support.
Determine if an IDE is Needed
This section provides investigators with information regarding whether an Investigational Device...
Determine if an IND Application is ...
This section provides investigators with information regarding whether an Investigational New Drug...
Guidance and Review of Issues related to Export Control Laws.
Getting Started with INDs / IDEs
Guide to getting started with IND and IDE submission protocols.
Human Research Protection Training
Resources for Completing Human Research Protection Program Training.
IDS Protocol Submission and Budget ...
Send a copy of your protocol and pharmacy manual, if one is available.
IDS Site Visit and Protocol ...
Schedule IDS site visit and protocol training.
IDS Study Maintenance & Closure
Notify the IDS when involvement is no longer necessary and schedule a closeout visit, if one is...
IND IDE Scientific Review
Provides Required Peer Feedback for Investigator Held IND & IDE Submissions.
IND/IDE Investigator Resources
The IND/IDE office provides guidance and training to Investigators regarding the requirements and...
IND/IDE Monitoring Services
Children's Hospital of Philadelphia Sponsor-Investigator Monitoring Resources.
Investigational Product Prescribing ...
Develop product prescribing and dispensing procedures for your study.
Policy & Procedure Management
Support for Research Institute Administrative Policy Management.
Quality Assurance, and Audit ...
Conduct quality assurance, education, and audit preparation activities.
Report Compliance Concerns
To report compliance concerns anonymously, contact the Compliance Hotline 1-866-246-7456.